Lead Molecular Biology Scientist, Analytical Development

CHEManager International; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Kenai Therapeutics in San Diego, CA, is seeking a highly motivated Scientist to join the Analytical Development team to support development, optimization and validation of molecular analytical methods for Kenai's programs from early development through to commercial launch.

The Scientist will work closely within the CMC team to deliver quality data by maintaining operations of extraction, manipulation and analysis of genetic material using various molecular biology techniques.

Qualifications

• PhD or MS with extensive analytical development experience
• Strong analytical skillset with deep expertise in various molecular biology assay development techniques, analysis and data interpretation
• Hands-on experience with cell handling of mammalian cells in lab operations
• Good understanding of ICH guidelines for analytical method development and validation and lifecycle management
• Experience with advanced instrumentation and software for PCR and molecular assays (Qiagen, ThermoFisher, Bio-Rad platforms)
• Familiarity with JMP, Prism or equivalent tools for statistics
• Strong technical writing abilities
• Knowledge of cell therapy product development and characterization
• Excellent organization and time management
• Ability to clearly analyze and communicate scientific findings

Responsibilities

• Lead assay design, development and qualification/validation of molecular biology assays
• Design, troubleshoot and execute lab daily activities including instrument setup and data analysis
• Maintain cell lines/banks for development work
• Establish standardized work templates and robust design strategies
• Conduct phase-appropriate robustness studies
• Generate and present scientific data in cross-functional meetings
• Maintain detailed lab records and electronic lab notebooks
• Apply statistical analysis using JMP/Prism to support experiments
• Prepare assay development reports and SOPs
• Conduct risk/gap assessments for method development
• Ensure assays meet regulatory expectations for cell therapy
• Keep up with literature and new technologies
• Partner with Process Development, Quality, Research and CROs to ensure analytical readiness
• Support method transfers/validation in GMP environments
• Demonstrate excellent written, verbal and interpersonal communication

Skills

Analytical skills

Molecular assay development

Data analysis

Cell culture handling

ICH guidelines

Statistical analysis

Technical writing

Cross-functional collaboration

Organization

Communication

Education

PhD in Immunology, Cell Biology, Neuroscience or related field

MS with 6+ years analytical development experience

Tools

Qiagen instruments

ThermoFisher systems

Bio-Rad platforms

QuantStudio

QX Manager

Quantasoft

Job description

Kenai Therapeutics in San Diego, CA, is seeking a highly motivated Scientist to join the Analytical Development team to support development, optimization and validation of molecular analytical methods for Kenai's programs from early development through to commercial launch.

The Scientist will work closely within the CMC team to deliver quality data by maintaining operations of extraction, manipulation and analysis of genetic material using various molecular biology techniques.